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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K070399
Device Name 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
Applicant
BIOMET MANUFACTURING, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0578
Applicant Contact TRACY B JOHNSON
Correspondent
BIOMET MANUFACTURING, INC.
P.O. BOX 587
WARSAW,  IN  46581 -0578
Correspondent Contact TRACY B JOHNSON
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Codes
LPH   LWJ   MAY   OQG   OQH  
Date Received02/12/2007
Decision Date 05/04/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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